Description and Brand Names

US Brand Name

Aptiom

Descriptions

Eslicarbazepine is used with other medicines to control partial seizures (convulsions) in the treatment of epilepsy.

Eslicarbazepine belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures as long as you continue to take it.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eslicarbazepine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of eslicarbazepine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving eslicarbazepine.

Pregnancy

Information about this eslicarbazepine-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate

Ado-Trastuzumab Emtansine

Alfentanil

Alprazolam

Amiodarone

Amitriptyline

Amlodipine

Apixaban

Aprepitant

Aripiprazole

Artemether

Astemizole

Atazanavir

Atorvastatin

Bedaquiline

Boceprevir

Bosutinib

Brentuximab Vedotin

Brinzolamide

Bromocriptine

Budesonide

Buprenorphine

Buspirone

Cabazitaxel

Cabozantinib

Canagliflozin

Carbamazepine

Carisoprodol

Ceritinib

Cilostazol

Cisapride

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clopidogrel

Clozapine

Cobicistat

Conivaptan

Crizotinib

Cyclophosphamide

Cyclosporine

Dabrafenib

Daclatasvir

Darifenacin

Darunavir

Dasatinib

Delavirdine

Dexamethasone

Diazepam

Dihydroergotamine

Docetaxel

Dolutegravir

Doxepin

Dronedarone

Dutasteride

Eletriptan

Eliglustat

Elvitegravir

Enzalutamide

Eplerenone

Ergotamine

Erythromycin

Escitalopram

Esomeprazole

Estradiol

Everolimus

Felodipine

Fentanyl

Fluticasone

Fosamprenavir

Fosphenytoin

Halofantrine

Haloperidol

Hydrocodone

Idelalisib

Iloperidone

Imatinib

Indinavir

Itraconazole

Ivabradine

Ketoconazole

Lacosamide

Lansoprazole

Letrozole

Levomilnacipran

Lomitapide

Lopinavir

Losartan

Lovastatin

Lurasidone

Maraviroc

Medroxyprogesterone

Mefloquine

Mephenytoin

Meprobamate

Methadone

Midazolam

Mifepristone

Mitotane

Nateglinide

Nelfinavir

Nifedipine

Nilotinib

Nisoldipine

Omeprazole

Ondansetron

Orlistat

Ospemifene

Oxycodone

Paclitaxel

Pantoprazole

Pazopanib

Perampanel

Phenobarbital

Phenytoin

Pimozide

Piperaquine

Pomalidomide

Ponatinib

Prednisolone

Prednisone

Primidone

Progesterone

Propafenone

Propranolol

Quetiapine

Quinidine

Quinine

Rabeprazole

Ranolazine

Regorafenib

Rifabutin

Rilpivirine

Riociguat

Ritonavir

Roflumilast

Rosuvastatin

Salmeterol

Saquinavir

Saxagliptin

Sildenafil

Siltuximab

Simeprevir

Simvastatin

Sirolimus

Sorafenib

Sunitinib

Tacrolimus

Tamoxifen

Tamsulosin

Telaprevir

Telithromycin

Temsirolimus

Terfenadine

Ticagrelor

Tipranavir

Tolvaptan

Trabectedin

Tramadol

Trazodone

Triamcinolone

Triazolam

Vandetanib

Vardenafil

Vemurafenib

Verapamil

Vilanterol

Vilazodone

Vincristine Sulfate

Vincristine Sulfate Liposome

Vinflunine

Voriconazole

Vortioxetine

Warfarin

Zaleplon

Zileuton

Ziprasidone

Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ethinyl Estradiol

Levonorgestrel

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Depression, history of or

Hyponatremia (low sodium in the blood) or

Mental illness, history of—Use with caution. May make these conditions worse.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may crush the tablets or swallow them whole. You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For seizures:

Adults—At first, 400 milligrams (mg) once a day. After one week, your doctor may increase your dose to 800 mg once a day. However, the dose is usually not more than 1200 mg once a day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Eslicarbazepine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause hyponatremia (low sodium in the blood). Check with your doctor right away if you have confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea or vomiting, swelling of face, ankles, or hands, or unusual tiredness or weakness while you are using this medicine.

Eslicarbazepine may cause some people to become dizzy, drowsy, clumsy, tired, or it may cause vision changes. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well. If these reactions are especially bothersome, check with your doctor.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking eslicarbazepine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having more seizures.

Birth control medicines may not work while you are using this medicine. Use another form of birth control to avoid getting pregnant. Other forms include condoms, a diaphragm, contraceptive foam, or jelly.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Confusion

decreased urine output

dizziness

fast or irregular heartbeat

fever or chills

increased in seizure frequency or severity

muscle pain or cramps

nausea or vomiting

severe thirst

shortness of breath

swelling of the face, ankles, or hands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

thoughts or attempts at killing oneself

upper right abdominal or stomach pain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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